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Posts posted by sgoertzen
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We designed and ordered special labels that we attach to our psoralen platelets. The ISBT codes for our products are E8331, E8332, E8333, E8334, E8335.
Psoralen-Treated Platelets
Place this label on all Psoralen-treated (Pathogen Reduced) INTERCEPT Platelets to remind the care provider that they are equivalent to IRRADIATED and to store at room temp.
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We've been using leukoreduced RBCs and PLTs in lieu of CMV seronegative for over 20 years for all pediatric (including neonate and micropremie) transfusions. I work at a 350 bed children's hospital with a large NICU, 3 satellite NICUs, an active ECMO and heart surgery program, and we care for many children who receive bone marrow or organ transplants. We converted to this back when studies showed that leukoreduced products were found to be basically equivalent to CMV seronegative products for rate of CMV transmission. We use leukoreduced for all transfusions (including exchange transfusions) regardless of patient age or size. We have never had a case of CMV transmission through transfusion. Over 80% of our blood donors are CMV positive in our area.
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I received this email below from jeskarmazinmd@gmail.com on 1/18/2019. You may want to contact Dr. Karmazin if you have any healthy plasma collected from young donors (16-25 yr old) that you would like to sell.
Hi, I am interested in setting up an account to order young plasma
(FFP), from donors ages 16-25.
My company, Ambrosia, is focused on using young plasma as a
restorative treatment for chronic illnesses. We have had success over
the last several years, including a clinical trial completed in 2018.
Please let me know if you have any questions.
Thank you,
Dr. Jesse Karmazin -
This is the way Meditech documents the splitting of products. Now with ISBT, the product code does not change when you split, so this is how the computer differentiates one split from another made from the same product. The split number (A, B, Ba, whatever) needs to print on the tag so you can tag the product properly and the blood bank and bedside staff know which split is being issued and transfused. I've had Meditech 27 years, we're a pediatric hospital so we make tons of aliquots, and no inspector (CAP, AABB, FDA, JC) has ever had a problem with this. Your CAP inspector should not cite you for something they don't understand. The previous post is correct - adding an A or B to the DIN when splitting has nothing to do with a closed or open system. I would challenge that citation.
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For many years we have been using borosilicate glass tubes (12 x 75mm and 10 x 75mm) with a patch for writing on them to perform our blood bank testing that needs to be done in tubes. We currently purchase ours from Kimble-Chase - item numbers are 60A10BZW and 60B12BZW. As companies have merged over the years I guess things have changed because one of our blood bankers recently noticed some very small print above the barcode on the box of tubes that says: "For Research use only. Not for use in diagnostic procedures." I would consider blood bank testing performed in tubes to be a "diagnostic procedure", so we've gone in search of an alternate vendor for glass tubes with a patch specifically made and approved for blood bank tube testing. We can't find anything out there on the market. We've checked with other local hospitals and they had never noticed this message until we brought it to their attention and are choosing to ignore the manufacturer's message and continue to use the tubes. What vendor is everyone else using?
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We've used TAR for years and it works well. We use the regular hospital ID band (where the barcode is the patient account number) - we do not use a special band. The nurses must scan the patient ID band and all 4 quadrants of the product label. We still require that 2 nurses Esign in TAR after completing their bedside checklist. We have built all their necessary non-scanable checks into this checklist (AAB Std 5.28.3). We use TAR everywhere except SURGERY, since they have their own system (called O.R. Manager) and they do not use Meditech in the surgery suites. We do not print a paper form for any location but SURGERY. For blood issue, we use a pick-up slip (we have them preprinted as pads that they keep at the nursing stations throughout the hospital) where they must fill out the patient name, MR#, Acct#, and what product they want to pick up.
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Beaker does not offer a blood bank module, so those hospitals going to Epic/Beaker must select some sort of standalone system for the blood bank. I'm interested to see comments because I will also be in this exact spot about 6 months from now (switching from Meditech 5.67) and I don't know which system to propose they purchase for just the blood bank department. Haemonetics SafeTrace, Mediware HCLL, Softbank, Sunquest????? I have no experience with any of them. Our whole hospital has been using Meditech since 1991. Those with experience integrating a blood bank system with Epic/Beaker... please offer your advice! We need a system that will accommodate bedside scanning/administration record, electronic crossmatch, as well as lots and lots of aliquoting and modifying since we are a children's hospital.
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Yes, we use this small 4C2223 tubing/filter set for transfusion of all blood products that they choose to pull into a syringe at the bedside.
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I've attached the form I came up with that we use.
Here is the section in my procedure that addresses method correlation:
CAP Checklist: COM.04250
If the laboratory uses more than one nonwaived instrument/method to test for a given analyte, the instruments/methods checked against each other at least twice a year for comparability of results.
NOTE: This requirement applies to tests performed on the same or different instrument makes/models or by different methods. This comparison must include all nonwaived instruments/methods. The laboratory must establish a protocol for this check that includes acceptance criteria. Quality control data may be used for this comparison for tests performed on the same instrument platform, with control materials of the same manufacturer and lot number. Otherwise, the use of human samples (whole blood, serum, plasma, urine, etc.) rather than stabilized commercial controls, is preferred to avoid potential matrix effects. In cases when availability or pre-analytical stability of patient/client specimens is a limiting factor, alternative protocols based on QC or reference materials may be necessary but the materials used should be validated (when applicable) to have the same response as fresh human samples for the instruments/methods involved.
Method Correlation is performed twice a year, comparing Echo1 vs. Echo2 vs. Manual Capture vs. Tube methods
1. ABO/Rh – No less than 3 specimens are compared, each with different blood types, at least one should be Rh negative
2. Antibody Screen – No less than 3 specimens are compared, at least one should be positive
3. Antigen Typing – comparing tube to Echo, no less than 3 specimens
4. Antibody ID – No less than 1 positive specimen is compared
Interpretation/ Acceptance Criteria:
· Manual and Automated Capture methods are expected to correlate closely.
· Echo1 vs. Echo2 results are expected to correlate (match) closely.
· Capture vs. Tube methods are expected to show some variability between reactions due to the differences in the nature of the testing systems and enhancements.
· Corrective action must be taken and documented when criteria are not met.
Hope this helps! Sheri
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Our entire hospital uses TAR...except Surgery. They refuse to use Meditech and use their own O.R. Manager system which does not interface with Meditech so their transfusions are still done on paper and are scanned into the EMR. So our big problems are with units started on the floor and transported with the patient to Surgery, and units started in Surgery and transported with the patient back out to the floor. We have to print paper transfusion forms for documenting either the beginning or end of those transfusions. We have never used separate BB bands but use the regular barcoded hospital band - both for inpatients and outpatients. We really like TAR. You can build the nursing checklists and vital screens with whatever fields you want completed. Unfortunately, Meditech has not built all screens/interventions/assessments with the capability of setting a requirement that the field MUST be completed prior to filing, so we occasionally still see some missed vitals, or missed checklist items (like a check for special requirements). Those "missing" items are now being tracked and reported as part of our ongoing quality monitors, and we've seen compliance get much better.
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Here is a copy of our Level 2 Annual Blood Bank Competency form. We also have a Level 1 (for just label checking and issuing blood), and a Level 3 for advanced Blood Bank competencies.
- lawblood, emeraldquest and AMcCord
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3
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AABB Std 5.25.5 requires "The records shall contain a signed statement from the requesting physician indicating that the clinical situation was sufficiently urgent to require release of blood before completion of compatibility testing or infectious disease testing".
Notice that this requirement is not hinged on whether the patient actually gets transfused with the emergency released blood. The fact that blood was requested prior to completion of testing requires the physician's signed statement, regardless of whether they end up transfusing it or not. So yes, you need to keep the emergency release form with the physician signature. If the form is returned with no signature, you should also chase the doctor down and get that signature, even if the blood was not given. It can be a hassle, but those are the standards.
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I am not familiar with Meditech but I would not forget to test some oddball scenarios to make sure the logic holds. For example, if you divide units try dividing both before and after performing EXM. If Meditech allows the user to edit/delete a unit blood type you should test that as well, especially after the EXM has been performed but before the unit is issued. What if units are electronically crossmatched on yesterdays sample and you get a new sample today and identify an antibody? If you try to issue the EXM compatible units does the system alert you? When you validate, you try to poke holes in the existing logic. The straightforward scenarios will likely validate just fine.
We have validated the electronic crossmatch with Meditech CS 5.65 and I agree with bmarotto. We followed the Meditech validation plan, but then also created additional "stress" situations as mentioned above (age of specimen, aliquots, modified products, previous positive Ab screens, different types of antibodies, etc.). The computer is using rules and logic from several areas to determine whether the EXM should invoke or not, but this isn't RBC product code dependent. I don't feel it's necessary to validate every single product with every possible donor type, since Meditech is simply looking at whether the product requires a crossmatch or not, and if it does, all the EXM rules automatically trigger. You've already validated all of your blood type compatibility truth tables. Good luck with your validation. You will love using the EXM!
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I now have funds available for purchase of a new plasma thawer. We have always used the Helmer DH8 and have had no real problems with it - we just wore it out! I'm interested in seeing if anyone has purchased the new "Plasmatherm" made by Barkey and sold by Genesis BPS? If so, what is your impression of it? Does it thaw as rapidly as the Helmer waterbath type of thawer? I understand it only thaws 4 plasma units at a time, but how does it work with cryo? Do you lay cryo bags on top of each other to thaw more units rapidly? Is maintenance really as easy as they say?
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Actually, we are STILL in the process of trying to get the Trucise system all built and validated. It apparently was not created to do a label verify comparison of all 4 quadrants of the ISBT label (as the folks at Terumo originally promised it could), so we are still working with them to create workarounds to get it to do at least the donor number and ABO/Rh. We're still having issues with the product code and expiration date/time. In preparation for using the Trucise, we switched to ordering and using only supplies (bags and syringes) that have barcoded lot numbers. We were using CharterMed which has no barcodes and switched to Fenwall that does have barcodes. The other option would be to print your own little barcodes and attach them to each set or box so you have something to scan.
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Can someone give us a reference for the AABB bulliten in question?
Thanks, Scott
AABB Association Bulletin #12-04 - Recommendation to Address Residual Risk of Bacterial Contamination of Platelets
Dated October 4, 2012
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AABB Standard 5.25.5 requires a signed statement from the requesting physician.
CAP requirement TRM.40770 also states that you must have records of emergency release (documented) authorization by a qualified physician.
Neither make an allowance for a PA or NP or RN. It must be the physician, but there are no specified time frames for getting the signature.
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We also have a Helmer 8 slot and like it a lot. But... have you seen the new Genesis (Barkey) "Plasmatherm"? It looks to have a small footprint, thaws 4 units at a time, and the quote I received from Genesis is less than the new Helmer waterbath I was planning on buying. I just wish the product brochure gave estimated thaw times, because that is an important factor to consider.
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What do you consider customer complaints? Only patient or doctor complaints or all "write-ups"?
Also, do you have a clear definition of a "near miss" or is it just based on your judgment?
A customer complaint could be from anyone: doctor, nurse, nursing staff, or patient/family. They can come as email, phone call or through the hospital QA system. We also track the complaints we occasionally have with our blood supplier (delays, product shortages, mislabeled historical Ag negative units, etc). Those get reported back to the blood supplier in a report each quarter.
Near misses are pretty much a judgement call on my part. I always consider... if someone would not have caught and corrected this mistake, would it have negatively impacted the safety of a patient? If the answer is Yes, I consider it to be a near miss. On our lab variance form, we have a grading key with these definitions:
Grade (severity)
0 = No Grade level required: Not Applicable
1 = No clinical harm or injury to patient/staff. (Inconvenience, delay, patient redraw, customer dissatisfaction)
2 = Potential for or actual mild harm/cost. (Self-limited, recovery complete, little to no discomfort, unnecessary expense)
3 = Potential for (near miss) or actual moderate harm. (Definitive treatment required, prolonged hospital stay)
4 = Potential for (near miss) or actual severe harm. (Life-threatening, permanently disabling, death)
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At my hospital, we split out our Blood Utilization monitoring like this (below) to cover each of these 10 AABB requirements:
1. Ordering Practices: C/T Ratios (Total and by Service), Uncrossmatched Blood Requests, Compliance with MD signature completion on "Release of Uncrossmatched Blood" forms
2. Patient Identification: Any Patient ID issues identified are reported
3. Sample Collection and Labeling: BBK Specimen acceptability report (outliers are detailed)
4. Infectious and Noninfectious Adverse Events, Incidence of Mistransfusion: Transfusion Reactions, Recalls, Notifications
5. Near-Miss Events: Anything identified would be detailed along with root-cause, corrective action
6. Usage and Discard: Units transfused, Units discarded
7. Appropriateness of Use (for all Components):
QA Audits performed by Medical Director, report pulls 100% products transfused (one type of product per month) and the most recent related lab data to when the product was issued. Outliers are investigated by the Medical Director. MDs receive follow-up letters on questionable transfusions.
Jan/Apr/Jul/Oct = RBC compared to most recent Hgb/Hct
Feb/May/Aug/Nov = PLT compared to most recent PLT count
Mar/Jun/Sep/Dec = FFP and CRYO compared to most recent PT/PTT and Fibrinogen
We also review any Autologous transfusions, Peri-Op Collection/Reinfusion (Cell Saver, Hemodilution, ECMO) and Therapeutic Apheresis and Phlebotomies performed during the quarter.
8. Blood Administration Policies and Practices: Our QA department performs random audits on 75 transfusions per quarter (coordinated with the RBC, PLT, and FFP/CRYO schedule above) and audits for MD Order to Transfuse, Issue Checks Performed, Bedside Checks Performed, Vitals Recorded. Since we are using TAR, all transfusion data is now entered into the computer so this audit can be done using computer reports. We also audit 100% of all transfusions for "Duration Less than 4 Hours" by running a computer report. We also report on Bedside Blood Administration Audits which are performed by the blood bank techs (minimum of 16 per year) and Blood Warmer QC which is performed quarterly by Biomed.
9. Ability of Services to Meet Patient Needs: We do Turnaround Time studies (Type & Screen, DAT, Crossmatch, Newborn Workup), report on any Customer Complaints and Cancelled Treatments. We also have a Bloodless Medicine and Surgery program so we report on the number of patients enrolled in the program who were treated without transfusion.
10. Compliance with Peer Review Recommendations: Letters Written/Sent to Phsyicians from the Medical Director and/or Blood Utilization Committee Chair, and Responses Received
I know, some of these do overlap somewhat, but "Ordering Practices" would be looking at how many and what kinds of products are doctors routinely ordering for various things (i.e. are they over-ordering or under-ordering for certain types of surgeries/procedures, do they order uncrossmatched too often because lack of ordering in advance) and "Appropriateness of Use" would be looking at whether they make the decision to actually transfuse those ordered products to their patients based on appropriate criteria (lab results, patient symptoms, etc.).
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We prepare small aliquots into ISBT labeled and tagged bags, and nurses pull the product into a syringe at the bedside using a small Y-Set (Baxter 4C2223, 13 inches) with an in-line filter. The labeled/tagged bag is NEVER disconnected from the syringe throughout the transfusion. The syringe simply becomes a part of the line from the bag to the patient. We've been doing it this way for years and it works very well.
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We are also on 5.65, but we are ISBT128 and don't have any problems with product code recognition during bedside scanning. Do you have separate product dictionaries built for each of your products, or do you have multiple codes mapped to one pheresis product? Just wondering whether maybe that could be the problem?
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We've been using Meditech TAR for a little over a year now in all areas except outpatient (HEM/ONC) clinics and Surgery. We still issue paper forms to those areas. We had extensive hands-on training for every nurse in the TEST system prior to Go-Live which included creating mock products, tags, labels, & armbands so every nurse could go through the entire transfusion process (scanning, vitals, begin, reactions, end). It took 9 weeks to get everyone trained and was a massive endeavor. We audit every transfusion to ensure that begin to end times are no longer than 4 hours (wrote a custom report that pulls outliers) and I file a hospital QA report on each of these. Usually, they forgot to "End" the transfusion in the computer, but it still stands as the official transfusion record so its not OK. The number of these dramatically dropped after the directors realized they would be getting QA reports on every outlier and would need to write an explanation. We also audit 25 transfusions per month (75 per quarter) to ensure that all of the nursing checklist and vitals are done appropriately. I file hospital QA reports on each of these outliers as well, and again, it took about a 6 month learning curve and diligence with filing QA reports, but things have greatly improved and now we are only seeing a few fall out each quarter.
Did you set up the nursing bedside scanning and checklist with the bypass option? We chose to not allow the nurses the option to bypass any of the TAR system, so if they are going to document the transfusion at all, they have no option but to use TAR (or if they are having trouble with scanning in TAR, they can always call the blood bank and ask for a paper form which must then be scanned into the electronic record).
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Those indicators sound really good, except for the "disposable" part. I wonder why someone has not created indicators like this that we could re-use over and over, that are good for a certified amount of time (like a year or two). They would be perfect for coolers and transport containers. C'mon manufacturers! This is what we need! You would sell truckloads of those things!
2nd ABO
in Transfusion Services
Posted
Someone above commented that a 2nd sample is only required in the U.S. for computer crossmatch (which used to be true). But with the 31st Edition of AABB Standards (effective April 1, 2018), this requirement was moved so that it now applies for all pretransfusion testing for allogeneic transfusions including all types of crossmatching (IS, AHG, and Computer crossmatching). This is more in line with CAP requirements and makes more sense in order to detect possible Wrong Blood In Tube (WBIT) events.
AABB Standards for Blood Banks and Transfusion Services, 31st Edition
5.14.5 Pretransfusion Testing for Allogeneic Transfusion
There shall be two determinations of the recipient’s ABO group as specified in Standard 5.14.1. The first determination shall be performed on a current sample, and the second determination by one of the following methods:
Testing a second current sample.
Comparison with previous records.
Retesting the same sample if patient identification was verified using an electronic identification system or another process validated to reduce the risk of misidentification.
Standards 5.11 and 5.27.1 apply.
Personal Note: If you intend to retest the same sample (by a different person or the same person), be prepared to show the AABB assessor your validation proving that your "another process" is actually validated to reduce the risk of misidentification (i.e. WBITs).
CAP Checklist Requirements:
TRM.30575 Misidentification Risk
The facility has a system to reduce the risk of mistransfusion for non-emergent red cell transfusions.
NOTE: Mistransfusion occurs from misidentification of the intended recipient at the time of collection of the pretransfusion testing sample, during laboratory testing and preparation of units to be issued, and at the time of transfusion. Misidentification at sample collection occurs approximately once in every 1,000 samples, and in one in every 12,000 transfusions the recipient receives a unit not intended for or not properly selected for him/her. The laboratory is expected to have implemented a plan to reduce these risks through implementation of a risk-reduction system. Among options that might be considered are: (1) Verifying the ABO group of the intended recipient on a second sample collected at a separate phlebotomy (including the recording of the result in the institution's historical record); (2) Utilizing a mechanical barrier system or an electronic identification verification system that ensures that the patient from whom the pretransfusion specimen was collected is the same patient who is about to be transfused. Other approaches capable of reducing the risk of mistransfusion may be used. The laboratory should participate in monitoring the effectiveness of the system that it implements. The laboratory should also consider improvements in procedures and/or educational efforts as part of its program to reduce the risk of mistransfusion.
TRM.40670 ABO Group and Rh(D) Type Verification
The recipient's ABO group and Rh(D) type has been verified by repeat testing of the same sample, a different sample, or agreement with a historical type in the laboratory's records.
NOTE: Repeat testing of the same sample may be inadequate unless the sample has been drawn using a mechanical barrier system or digital bedside patient identification system. For laboratories that employ computer crossmatching, serologic crossmatch techniques must be employed when ABO typing discrepancies are present (e.g. mixed field reactivity, missing serum reactivity, apparent change in blood type post hematopoietic stem cell transplant).